MAUDE Adverse Event Report: ZYNO MEDICAL, LLC ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM; LARGE VOLUME INFUSION PUMP

Model Number Z-800WF

Device Problems Backflow (1064); Improper Flow or Infusion (2954); Infusion or Flow Problem (2964); No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/11/2019

Event Type  malfunction  

Manufacturer Narrative

The actual device was tested by the service provider on (b)(6) 2019.The pump passed the flow rate testing.The reported backflow phenomenon could not be replicated.The pump met all specifications as intended.The complaint couldn't be confirmed.

Event Description

On 09/17/2020, a distributor of zyno medical reported a complaint.A user facility representative contacted the distributor on (b)(6) 2019, and stated that pump 502617 patient noticed "blood was coming back".The pump said it was running but no fluids were being infused.The device operator was a registered nurse.Medication being infused was saline.There was a patient involved.The patient was not harmed or injured.

• Brand Name: ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM
• Type of Device: LARGE VOLUME INFUSION PUMP
• Manufacturer (Section D): ZYNO MEDICAL, LLC; 177 pine street; natick MA 01760
• Manufacturer (Section G): ZYNO MEDICAL, LLC; zyno medical, llc; 177 pine street; natick MA 01760
• Manufacturer Contact: chaoyoung lee ; 177 pine street; natick, MA 01760 ; 5083158202
• MDR Report Key: 10650044
• MDR Text Key: 210493325
• Report Number: 3006575795-2020-00021
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 00814371020037
• UDI-Public: 00814371020037
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130690
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: Z-800WF
• Device Catalogue Number: Z-800WF
• Device Lot Number: 20161021-SH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/08/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/29/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1